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AI Diagnoses Lung Cancer With Unprecedented Accuracy
3 Jul
Summary
- AI software eyonis LCS received CE marking in Europe.
- It combines detection and diagnosis for lung cancer.
- The AI shows higher sensitivity and specificity than doctors.
Median Technologies has achieved a significant milestone with its eyonis LCS receiving CE marking under the European Medical Device Regulation (MDR 2017/745). This designation, granted by GMED, allows the artificial intelligence-based Software as a Medical Device (SaMD) to be marketed throughout the European Economic Area.
This European approval follows eyonis LCS's clearance by the US Food and Drug Administration (FDA) in February 2026. The device is designed to assist clinicians in identifying and characterizing lung nodules on low-dose computed tomography (LDCT) scans, thereby supporting early lung cancer diagnosis and risk assessment.
The AI's dual approval across major markets aims to tackle critical challenges in lung cancer screening, specifically the prevalent issues of false positives and negatives. Median Technologies reports that eyonis LCS is the first system to integrate both computer-aided detection and diagnosis within the LDCT screening pathway.
Internal data from Median Technologies indicate that eyonis LCS demonstrates a sensitivity of 93.3% and a specificity of 92.4%. These figures significantly surpass the reported 80.3% sensitivity and 76.4% specificity associated with traditional radiologist screening. This advancement promises more accurate and accessible early lung cancer detection for eligible patients.
